Clinical trials: Aortic Disease
Severe Aortic Stenosis
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- HORIZON CANADA (NCT02159794)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- Canada
- Sponsor
- HLT Inc.
Abdominal Aortic Aneurysms
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac…
- Trial name
- PYTHAGORAS (NCT00522535)
- Testing
- Open surgical repair, Stent Graft
- Where
- 38 sites in United States
- Volunteers
- 230 people
- Sponsor
- Lombard Medical
Abdominal Aortic Aneurysms
The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study
The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical…
- Trial name
- NCT01346943
- Testing
- Altura Medical Abdominal Aortic Aneurysm Stent-Graft
- Where
- 2 sites in Chile, Latvia
- Volunteers
- 50 people
- Sponsor
- Altura Medical Inc.
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Cardiomyopathy, Hypertrophic
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
The purpose of this study was to determine if LCZ696 can improve functional capacity (via improved peak VO2) in non-obstructive hypertrophic cardiomyopathy (HCM) patient population over the course of 50 weeks of treatment.
- Trial name
- NCT04164732
- Testing
- LCZ696
- Where
- 18 sites in United States, Germany and 4 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
J-Valve Transfemoral Pivotal Study
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed…
- Trial name
- JOURNEY (NCT06455787)
- Testing
- J-Valve Transfemoral (TF) System
- Where
- 42 sites in United States, Canada and 3 more
- Volunteers
- 194 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Terumo Aortic Global Endovascular Registry
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
- Conditions
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery
- Trial name
- TiGER (NCT04246463)
- Testing
- Thoracic, Abdominal, Custom Device
- Where
- 58 sites in United States, Belgium and 8 more
- Volunteers
- 1,000 people
- Sponsor
- Vascutek Ltd.
Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm
ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT
The objective of this retrospective observational study is to evaluate the theoretical anatomical suitability of the new Braile off-the-shelf multi-branched endograft in patients with thoracoabdominal aneurysm.
- Conditions
- Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm, Vascular Diseases, Aortic Diseases
- Trial name
- BMETA (NCT07118995)
- Testing
- Analysis of preoperative CTA
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aneurysm, Dissection
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
- Conditions
- Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection
- Trial name
- PANTHER (NCT04545502)
- Testing
- Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch
- Where
- 30 sites in United States, Belgium and 4 more
- Volunteers
- 2,000 people
- Sponsor
- Vascutek Ltd.
Aortic Arch; Aneurysm, Dissecting
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation…
- Trial name
- NCT03735472
- Testing
- Thoraflex™ Hybrid
- Where
- 37 sites in France
- Volunteers
- 351 people
- Sponsor
- Vascutek Ltd.
Aortic Dissection
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)
To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.
- Trial name
- FLAGSHIP_FRA (NCT06740721)
- Testing
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
Abdominal Aortic Aneurysm
LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the low profile Ovation ® Abdominal Stent Graft Platform when used in the endovascular treatment of female…
- Trial name
- LUCY (NCT02479191)
- Testing
- Ovation Abdominal Stent Graft Platform
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- TriVascular, Inc.
Aortic Arch Aneurysm
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.
- Trial name
- NCT06385379
- Testing
- WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
- Where
- 20 sites in China
- Volunteers
- 90 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Aortic Valve Stenosis
VitaFlowTM II Transcatheter Aortic Valve System Study
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic…
- Trial name
- NCT03575039
- Testing
- VitaFlow II Transcatheter Aortic Valve System
- Volunteers
- 178 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Heart Failure, Acute Decompensated Heart Failure
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance
- Conditions
- Heart Failure, Acute Decompensated Heart Failure, Cardiorenal Syndrome, Heart Failure, Congestive
- Trial name
- NCT06174623
- Testing
- ModulHeart Support
- Where
- 5 sites in Australia, Georgia
- Volunteers
- 5 people
- Sponsor
- Puzzle Medical Devices Inc.
Aortic Valve Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices